Sustained Release Oral Formulation For Treatment Of Parkinsons Disease

NCT07709741 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: NEUR-2021-29687
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

LD/CD (medications to treat Parkinson's disease) will be delivered using an assembly of nested sachets made of permeable material. The assembly is placed in the oral/buccal cavity (between cheek and gum of lower jaw) and delivers continuous release of CD and LD for both transmucosal and gastrointestinal absorption. The combination of CD/LD in the inner sachet varies from that in the outer sachet. This allows for sequential release of CD and then LD to mimic a CD pretreatment method which is known to increase LD absorption and prolong its half-life.

Conditions

Healthy Volunteers

Keywords

Parkinson's; Levidopa; Carbidopa

Outcome Measures

Primary Outcomes (22)

• Blood CD Level - Minute 15

  Measured in \[ng/mL\]

  Minute 15 after administration

• Blood LD Level - Minute 15

  Measured in \[ng/mL\]

  Minute 15 after administration

• Blood CD Level - Minute 30

  Measured in \[ng/mL\]

  Minute 30 after administration

• Blood LD Level - Minute 30

  Measured in \[ng/mL\]

  Minute 30 after administration

• Blood CD Level - Minute 45

  Measured in \[ng/mL\]

  Minute 45 after administration

• Blood LD Level - Minute 45

  Measured in \[ng/mL\]

  Minute 45 after administration

• Blood CD Level - Hour 1

  Measured in \[ng/mL\]

  One hour after administration

• Blood LD Level - Hour 1

  Measured in \[ng/mL\]

  One hour after administration

• Blood CD Level - Hour 2

  Measured in \[ng/mL\]

  Two hours after administration

• Blood LD Level - Hour 2

  Measured in \[ng/mL\]

  Two hours after administration

• Blood CD Level - Hour 3

  Measured in \[ng/mL\]

  Three hours after administration

• Blood LD Level - Hour 3

  Measured in \[ng/mL\]

  Three hours after administration

• Blood CD Level - Hour 4

  Measured in \[ng/mL\]

  Four hours after administration

• Blood LD Level - Hour 4

  Measured in \[ng/mL\]

  Four hours after administration

• Blood CD Level - Hour 5

  Measured in \[ng/mL\]

  Five hours after administration

• Blood LD Level - Hour 5

  Measured in \[ng/mL\]

  Five hours after administration

• Blood CD Level - Hour 6

  Measured in \[ng/mL\]

  Six hours after administration

• Blood LD Level - Hour 6

  Measured in \[ng/mL\]

  Six hours after administration

• Blood CD Level - Hour 7

  Measured in \[ng/mL\]

  Seven hours after administration

• Blood LD Level - Hour 7

  Measured in \[ng/mL\]

  Seven hours after administration

• Blood CD Level - Hour 8

  Measured in \[ng/mL\]

  Eight hours after administration

• Blood LD Level - Hour 8

  Measured in \[ng/mL\]

  Eight hours after administration

Study Arms (3)

Formulation A

ACTIVE COMPARATOR

Two sachets nested between the lower jaw, gum, and cheek; outer sachet 100 mg CD/0mg LD and inner sachet 0mg CD /400mg LD

Drug: Formulation A

Formulation B

ACTIVE COMPARATOR

Two sachets nested between the lower jaw, gum, and cheek; outer sachet 150mg CD/0mg LD and inner sachet 600mg LD

Drug: Formulation B

Formulation C

ACTIVE COMPARATOR

Two sachets nested between the lower jaw, gum, and cheek; outer sachet 200mg CD/0mg LD and inner sachet 800mg LD

Drug: Formulation C

Interventions

Formulation A DRUG

outer sachet 100 mg CD/0mg LD and inner sachet 0mg CD /400mg LD

Also known as: Study Drug A

Formulation A

Formulation B DRUG

outer sachet 150mg CD/0mg LD and inner sachet 600mg LD

Also known as: Study Drug B

Formulation B

Formulation C DRUG

outer sachet 200mg CD/0mg LD and inner sachet 800mg LD

Also known as: Study Drug C

Formulation C

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult healthy male or female
• Age 18 to 65 years
• Willingness and ability to complete study procedures

You may not qualify if:

• medical conditions that require taking medications regularly.

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Khalaf Bushara, MD, FRCP

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Khalaf Bushara, MD, FRCP

CONTACT

‪(612) 460-5734‬; umnstudies@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a randomized, double-blind (dose-masked), single-dose crossover study to investigate the pharmacokinetics of a novel delivery method and formulation of different doses of CD/LD in normal volunteers.

Study Record Dates

• First Submitted: July 6, 2026
• First Posted: July 16, 2026
• Study Start: June 30, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: July 20, 2026

Record last verified: 2026-07

Locations

US (1)